Tau PET Outcomes With Anti-amyloid Immunotherapies

November 16, 2025 updated by: Petrice M. Cogswell, Mayo Clinic

Study of Tau PET Outcomes in Patients Receiving Anti-amyloid Immunotherapies

This is an imaging study of patients with mild Alzheimer's disease receiving amyloid-targeting therapy and under the care of neurologists at Mayo Clinic in Rochester, MN.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 50-90 years
  • Male or female
  • Mild cognitive impairment due to AD or mild AD
  • Amyloid positive via CSF or PET
  • Meets other eligibility criteria for anti-amyloid immunotherapy
  • Subject or delegate provides informed consent

Exclusion Criteria

  • Subjects unable to lie down without moving for 10 minutes.
  • Women who are pregnant or cannot stop breast feeding for 24 hours.
  • Claustrophobic patients unable to tolerate the scans (no sedation can be offered).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Untreated historical controls enrolled in Mayo Clinic Study of Aging (IRB 14-004401), Mayo Alzheimer's Disease Research Center (IRB 712-98), and Brain Amyloid Imaging with Pittsburgh Compound B in Normal Aging, Mild Cognitive Impairment, and Dementia (IRB 08-005553).
Experimental: Treatment Group
Subjects with a diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease and amyloid positive, who are starting anti-amyloid immunotherapy.
Drug: 18F-AV-1451

Subjects will receive two Tau PET (18F--AV-1451) brain scans with approximately 10 mCi (370 MBq) (+/- 10%mCi) of 18F-AV-1451. Images will be collected for a 20-minute acquisition between 80-100 minutes after injection.

Tau PET scans will occur at baseline and 12-18 months after completing anti-amyloid immunotherapy treatment..

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in tau PET Standardized Uptake Value (SUVR)
Time Frame: Baseline, 18 months
A PET Standardized Uptake Value (SUV) is measured by calculating the ratio of the radioactivity concentration within a specific region of interest (ROI) on a PET scan, divided by the injected dose of the radiotracer per unit of the patient's body weight. The calculated Standardized Uptake Value (SUVR) is reported as a single number, with higher values indicating greater tracer uptake in the target region relative to the reference region
Baseline, 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of subjects to develop amyloid-related imaging abnormalities (ARIA)
Time Frame: 18 months
ARIA is defined as edema (parenchymal edema or sulcal effusion, ARIA-E) and hemorrhage (microhemorrhages and superficial siderosis, ARIA-H). ARIA is detected on the patient's routine clinical brain MRIs.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Petrice Cogswell, M.D., Ph.D., Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

December 5, 2024

First Posted (Actual)

December 9, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-004371

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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